Expert on assigned trials as the Lead Study Coordinator where they are responsible for ongoing, active communication of study progress and questions. Oversees all aspects of the trial. Delegates tasks appropriately and ensures all appropriate staff has the necessary training. Performs study visits.
Essential Job Functions
- Lead Study Coordinator on 4-8 trials at a time
- Be an expert on assigned trials, overseeing all aspects of the trial with oversight by the PI
- Responsible for ongoing, active communication of study progress, questions, issues with Investigator and sub-investigator
- Lead Study Review on assigned trials
- Ensure appropriate staff have all necessary documented training on assigned trials
- Ensure RCR delegation of Authority log has been signed doff appropriately prior to individuals prior to performing study-related tasks
- Ensure study source documents for assigned trials reflect all necessary data points per protocol and data capture system, using the RCR template and process (clerical assistance) including inclusion/exclusion and appropriate involvement of PI and in conjunction with QA director template and review
- Ensure all study supplies for assigned trials are received and sufficient for study goals
- Ensure study drug is dispensed, accounted for, and returned to the Sponsor per protocol
- Act as the Sponsor’s monitor primary site contact
- Ensure SAE’s are reported to Principal Investigator, Sponsor, and IRB (through Regulatory) in a timely manner, collect all information to report the event, follow up appropriately
- Ensure complete and timely review of all study procedures
- Responsible for delegating work, outcomes, and general oversight of their assigned Research Assistant
- Perform study visits
- Accurately complete study sources for any of the site’s ongoing studies once delegated and trained on the protocol prior to performing study-related tasks
2 years of clinical nursing experience required. Strong clinical background with evidence of independent clinical assessment skills and strong attention to detail preferred.
RN/ LPN from 2, 3, or 4-year program is required.
CCRC preferred not mandatory at the time of hire.